K-number	K151786
Device name	Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
Applicant	Roche Diagnostics
Product code	CDD
Device class	Class II
Decision date	Sep 24, 2015
Decision	Substantially Equivalent
Regulation	862.1810

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View the full FDA submission: accessdata.fda.gov

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Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

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